Silicone rubber is the material of choice for implants because it does not react to the human body and the body does not react to it. Moreover, it is easily molded into any desired shape and holds its shape in perpetuity.
Chin implants made of silicone are well known. In U.S. Pat. No. 4,713,077 to Small, a silicone chin implant is combined with a biologically acceptable metal for securing the implant. Significantly, the consistency of the silicone is uniform throughout the implant.
A silicone rubber breast implant is shown in U.S. Pat. No. 3,681,787 to Perras; as in the Small device, the silicone rubber part of the implant has a uniform consistency.
There are numerous other patents and publications disclosing differing prosthetic devices for implanting in differing parts of the body, and all of them share a common structural feature: all parts of the respective implants have the same hardness as all other parts thereof.
Prior to the filing of this disclosure, no worker in the field of silicone rubber implants had considered the desirability of the known structures. Everyone knows that the tip of the human nose is soft and flexible, and that the columella and dorsum parts thereof are hard, for example, but the art of prosthetic devices has failed to address the implications of this fact. The present inventor is the first, anywhere in the world, to observe the unsatisfactory nature of the presently available devices, said unsatisfactory nature being a result of the uniform hardness of the devices. An individual fitted with a silicone rubber nose, for example, has a hard columella and an equally hard dorsum, which is suitable and satisfactory, but has an equally hard nose tip, which is not. Similarly, the tip or leading end of a human chin is relatively soft, but a prosthetic chin made by known methods is equally hard at all locations.
The prior art, when considered as a whole in accordance with the requirements of law, neither teaches nor suggests to those of ordinary skill in this art how the limitations thereof could be overcome.